Pulmonary hypertension in interstitial lung disease: Clinical trial design and endpoints: A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative-Group 3 Pulmonary Hypertension

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• dc.contributor.author Nathan, Steven D.
• dc.contributor.author Fernandes, Peter
• dc.contributor.author Psotka, Mitchell
• dc.contributor.author Vitulo, Patrizio
• dc.contributor.author Piccari, Lucilla
• dc.contributor.author Antoniou, Katerina
• dc.contributor.author Nikkho, Sylvia M.
• dc.contributor.author Stockbridge, Norman
• dc.date.accessioned 2024-05-16T06:26:18Z
• dc.date.available 2024-05-16T06:26:18Z
• dc.date.issued 2022
• dc.description.abstract Pulmonary hypertension (PH) associated with interstitial lung disease (ILD) is an attractive target for clinical trials of PH medications. There are many factors that need to be considered to prime such studies for success. The patient phenotype most likely to respond to the intervention requires weighing the extent of the parenchymal lung disease against the severity of the hemodynamic impairment. The inclusion criteria should not be too restrictive, thus enabling recruitment. The trial should be of sufficient duration to meet the chosen endpoint which should reflect how the patient feels, functions, or survives. This paper summarizes prior studies in PH-ILD and provides a framework of the type of studies to be considered. Inclusion criteria, clinical trial endpoints, and pharmacovigilance in the context of PH-ILD trials are also addressed. Through lessons learnt from prior studies, suggestions and guidance for future clinical trials in PH-ILD are also provided.
• dc.format.mimetype application/pdf
• dc.identifier.citation Nathan SD, Fernandes P, Psotka M, Vitulo P, Piccari L, Antoniou K, et al. Pulmonary hypertension in interstitial lung disease: Clinical trial design and endpoints: A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative-Group 3 Pulmonary Hypertension. Pulm Circ. 2022 Oct 1;12(4):e12178. DOI: 10.1002/pul2.12178
• dc.identifier.doi http://dx.doi.org/10.1002/pul2.12178
• dc.identifier.issn 2045-8932
• dc.identifier.uri http://hdl.handle.net/10230/60169
• dc.language.iso eng
• dc.publisher Wiley
• dc.relation.ispartof Pulm Circ. 2022 Oct 1;12(4):e12178
• dc.rights © 2022 The Authors. Pulmonary Circulation published by Wiley Periodicals LLC on behalf of the Pulmonary Vascular Research Institute. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
• dc.subject.keyword Clinical trial design
• dc.subject.keyword Interstitial lung disease
• dc.subject.keyword Pulmonary hypertension
• dc.title Pulmonary hypertension in interstitial lung disease: Clinical trial design and endpoints: A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative-Group 3 Pulmonary Hypertension
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion